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Yoga to Reduce Cancer Fatigue

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00583739
First received: December 20, 2007
Last updated: December 3, 2008
Last verified: December 2008
History of Changes
  Purpose

A randomized trial from the British National Health Service found that supervised exercise benefits women with early stage breast cancer with improved functional and psychological benefit after a 12-week intervention and 6 months later. Considering the needs of breast cancer patients and survivors and the reported benefits of exercise and yoga intervention, the investigators propose a pilot study of an 8-week yoga intervention in breast cancer patients. This study would specifically address measures of fatigue and psychosocial distress in the population of breast cancer patients during treatment and within the year following treatment. Currently there is very limited literature on yoga intervention in this population.


Condition Intervention Phase
Breast Neoplasm
 Behavioral: Yoga
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of a Yoga Intervention on Fatigue, Distress, and Quality of Life in Breast Cancer Patients: A Randomized Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Determine if an 8 week yoga program designed for breast cancer patients improves subjective reports of overall well being and fatigue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analyze symptoms of depression and anxiety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Yoga intervention
 Behavioral: Yoga
Gentle Yoga for breast cancer survivors, 1 time weekly, for 8 weeks.
No Intervention: 2
Control. No Yoga for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Potential subjects must have had histologically or cytologically confirmed breast cancer. This includes, but is not limited to: breast cancer-in situ; ductal carcinoma in situ; lobular carcinoma in situ; cystosarcoma phyllodes; inflammatory breast carcinoma; invasive breast carcinoma; and breast cancer not otherwise specified; cancer must be stage 0 through stage III.
  • Treatment completion within the past calendar year.
  • Age ≥ 18 years. While breast cancer can occur in the pediatric population, the pediatric population is best served by trials specifically designed for their age group.
  • Life expectancy of greater than 1 year.
  • Karnofsky ≥ 60%; see Appendix A.
  • Women of childbearing potential are eligible for this study.
  • Pregnant women are eligible for this study pending a doctor's note.
  • The ability to understand and complete the study questionnaires.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients with known metastasis.
  • Patients who are actively participating in a yoga class.
  • Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would compromise subject health during yoga.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583739

Locations
United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Geraldine Jacobson, MD MPH department of radiation oncology
  More Information

Publications:

Responsible Party: Geraldine Jacobson, MD, MPH, Department of Radiation Oncology
ClinicalTrials.gov Identifier: NCT00583739     History of Changes
Other Study ID Numbers: 200707733
Study First Received: December 20, 2007
Last Updated: December 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Fatigue
Yoga
Anxiety
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Fatigue
Neoplasms by Site
 Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013